Post Marketing Safety Studies
It is not only about getting a drug or device on the market; it is also about gathering additional information on their use and performance on a larger scale. Observational studies provide high value information on how your product is used routinely and its real-life safety profile as these insights cannot be obtained from interventional clinical trials. For this reason, post-marketing surveillance studies are an integrated part of the Risk Management Plan of your product as they address questions which can only be detected once the product is on the market.
For these studies which are increasingly regarded as a responsibility and obligation of drug or device developers, we provide customised services, which can be deployed on a stand-alone basis or as part of an integrated solution. We can design specific studies to investigate topics pertaining to adverse drug reactions, unapproved or off-label drug use, use in paediatric populations, etc. We customise our offer and level of involvement to suit your specific requirements so you don’t have to buy the full package if you don’t need it.
Nevertheless, we pride ourselves on being flexible and agile, so if the unexpected does happen we will work with you to get things back on track.
- Post approval safety studies
- Risk-benefit profile
- Comparative effectiveness risk assessment
- Physician use
Call us to find out more about our PMSS solutions
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